Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes
2 other identifiers
interventional
140
1 country
2
Brief Summary
The goal of this clinical trial is to evaluate the efficacy of an adapted FAMS (Family/friend Activation to Motivate Self-care) intervention on CGM use among study participants who are CGM users. We will leverage the infrastructure of an NIDDK-funded RCT evaluating FAMS-T1D among N=280 emerging adults with T1D who have elevated hemoglobin A1c or elevated diabetes distress (NCT05820477). We anticipate at least 50% using CGM to be included in these analyses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2023
CompletedStudy Start
First participant enrolled
April 30, 2023
CompletedFirst Posted
Study publicly available on registry
May 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
October 29, 2025
October 1, 2025
3.8 years
April 24, 2023
October 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
CGM frequency of use during the intervention period
Change in CGM frequency of use assessed by self-report on questionnaire; more frequent use/higher is better
Baseline and 6 months post-baseline
CGM frequency of use during the intervention period
Change in CGM frequency of use assessed by objective CGM data (% of time; higher is better)
Baseline and 6 months post-baseline
Gaps in CGM use
Length of gaps in CGM use as assessed by objective CGM data (measured in number of consecutive days without CGM data; higher is worse)
6 months post-baseline
Secondary Outcomes (4)
CGM behavioral responses during the intervention period
Baseline and 6 months post-baseline
Barriers to CGM use during the intervention period
Baseline and 6 months post-baseline
Barriers to CGM use during the intervention period
Baseline and 6 months post-baseline
CGM satisfaction during the intervention period
Baseline and 6 months post-baseline
Other Outcomes (2)
Data sharing during the intervention period
6 months post-baseline
Satisfaction with data-sharing relationships
6 months post-baseline
Study Arms (2)
FAMS-T1D
EXPERIMENTALParticipants will receive FAMS-T1D components (monthly phone coaching and text message support for goals) for 6 months. Support persons will receive text messages that are tailored to the goal set by the person with type 1 diabetes. All persons with diabetes will receive text messages regarding how to access their HbA1c results and receive links providing information to assist them in self-care behaviors related to their diabetes. All support persons will also receive materials about type 1 diabetes and how to provide helpful support to the person with diabetes.
Digital resources for diabetes
PLACEBO COMPARATORAll persons with diabetes will receive text messages regarding how to access their HbA1c results and receive links providing information to assist them in self-care behaviors related to their diabetes. All support persons will also receive materials about type 1 diabetes and how to provide helpful support to the person with diabetes.
Interventions
FAMS-T1D involves monthly phone coaching that assists individuals in setting specific and time bound diabetes goals with automated text message support to the patient participant and less frequent automated text messages to their support person, if one is enrolled. Behavioral: Diabetes Resources High quality digital materials about diabetes management will be provided upon enrollment and send to participants quarterly.
Quality digital resources about diabetes management provided upon enrollment and during the study.
Eligibility Criteria
You may qualify if:
- PERSONS WITH DIABETES
- Ages 18-24
- Have a diagnosis of T1D and has been taking insulin for at least one year
- Comfortable sending and receiving texts
- Can speak, read, and write in English
- Meets one of the following two criteria: 1) has a most recent A1c value in the EHR that is 7.5% or higher (or missing) OR 2) screen positive for diabetes distress on the two-item Diabetes Distress Screen (DDS-2)
- Using a continuous glucose monitor (CGM)
- SUPPORT PERSONS
- Age 18 or older
- Can speak, read, and write in English or Spanish
- Comfortable sending and receiving texts
You may not qualify if:
- PERSONS WITH DIABETES
- Has a condition that would prohibit study completion (intellectual disability, blindness or auditory limitations, severe mental illness)
- Plans to live outside the country during the study period
- SUPPORT PERSONS
- Shares a phone with the person with diabetes
- Plans to live outside of the country during the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt University Medical Centerlead
- The Leona M. and Harry B. Helmsley Charitable Trustcollaborator
- University of Utahcollaborator
- University of California, Mercedcollaborator
- Children's Hospital Los Angelescollaborator
Study Sites (2)
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of Utah
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
April 24, 2023
First Posted
May 11, 2023
Study Start
April 30, 2023
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
April 30, 2027
Last Updated
October 29, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- After study results are posted on clinical trials and outcomes published in a peer-reviewed journal, until 5 years later.
- Access Criteria
- Contact the principal investigator
After study results are posted on clinical trials and published, de-identified data will be available upon requests made to the principal investigator.